Dental CariesNCT07427004
Sleep Problems, Salivary Biomarkers, Dental Caries and Periodontal Status in School-Aged Children
An observational study of Dental Caries and Sleep Problems, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Dental caries is one of the most prevalent chronic diseases in childhood. In addition to established etiological factors such as dietary habits and oral hygiene, biological and behavioral factors-including sleep disturbances and salivary biochemical characteristics-may contribute to caries development and periodontal… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Sleep Problems, Periodontal Status
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 73 healthy children aged 6-12 years (42 boys and 31 girls) were included in the study. The participants were divided into two groups: the study group (39 children with advanced dental caries, ICDAS II codes 5-6) and the control group (34 children who were caries-free or had initial-moderate caries, ICDAS II codes 0-4). Children with systemic diseases, conditions affecting salivary secretion, or recent use of medications influencing saliva were excluded. Written informed consent was obtained from the parents or legal guardians of all participants. Only children of Turkish ethnicty were included.
Who may be able to join
- Children aged 6-12 years
- Children with no systemic diseases
Who cannot join
- Children with systemic or local conditions affecting salivary secretion (diabetes, salivary gland infections, sialoliths, or neurological disorders)
- Children who had used medications affecting salivary secretion in the past three months (antimuscarinics, antihypertensives, or antidepressants)
- Children whose legal guardian did not provide written informed consent
- Children with the history of chemotheraphy or radiotherapy
- Children who are uncooperative with salivary sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children
Dental caries is one of the most prevalent chronic diseases in childhood. In addition to established etiological factors such as dietary habits and oral hygiene, biological and behavioral factors-including sleep disturbances and salivary biochemical characteristics-may contribute to caries development and periodontal health.
Saliva plays a critical role in maintaining oral homeostasis through its physical properties (flow rate, pH, and buffering capacity) and biochemical components. Salivary biomarkers such as melatonin, cortisol, interleukin-6 (IL-6) and oxidative stress parameters (total oxidant status [TOS], total antioxidant status [TAS], and oxidative stress index [OSI]) are associated with sleep regulation, stress response, inflammation and immune function.
Read more
This cross-sectional study aims to evaluate the relationship between sleep disturbances and salivary parameters as well as dental caries severity and periodontal status in children aged 6-12 years. A total of 73 children are categorized into two groups according to the International Caries Detection and Assessment System (ICDAS II): children with high-grade caries (codes 5-6) and children who are caries-free or have initial to moderate caries (codes 0-4).
All participants undergo a comprehensive oral examination to assess caries experience, plaque index, gingival index and bleeding on probing. Unstimulated saliva samples are collected to determine salivary flow rate, pH, buffering capacity, melatonin, cortisol, IL-6, TOS, TAS, and OSI levels. Sleep disturbances are evaluated using the Sleep Disturbance Scale for Children
- Conditions
- Dental Caries, Sleep Problems, Periodontal Status
- Medical subject headings
- Dental Caries, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Advanced Caries | Study Group (Advanced Caries): Children aged 6-12 years with advanced dental caries (ICDAS codes II 5-6). All participants were systemically healthy and of Turkish ethnicity. | |
| Contol Group: Caries-Free / Mild-Moderate Caries | Control Group (Caries-Free / Mild-Moderate Caries): Children aged 6-12 years with no or mild-moderate dental caries (ICDAS II codes 0-4).All participants were systemically healthy and of Turkish ethnicity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries severity
Assessed using the International Caries Detection and Assessment System (ICDAS II, codes 0-6) for each primary and permanent tooth. Higher codes indicate more severe lesions. 0 = sound, 1 = first visual change in enamel, 2 = distinct visual change, 3 = localized enamel breakdown, 4 = underlying dark shadow, 5 = distinct cavity, 6 = extensive cavity.
Measured: One-time, baseline (July-September 2024
Cumulative caries experience
Assessed using the DMFT + dmft index to record the total number of decayed (D/d), missing (M/m) and filled (F/f) teeth in permanent and primary dentition.
Measured: One-time, baseline (July-September 2024)
Periodontal status - Plaque index
Plaque accumulation assessed on all teeth using the Silness-Löe plaque index (score 0-3). 0 = no plaque, 1 = slight plaque visible, 2 = moderate plaque, 3 = abundant plaque. Higher scores indicate more plaque accumulation.
Measured: One-time, baseline (July-September 2024)
Periodontal status - Gingival index
Gingival inflammation assessed on all teeth using the Silness-Löe gingival index (score range 0-3). Scores obtained from each tooth. Score interpretation: 0 = normal gingiva, 1 = mild inflammation (slight color change, no bleeding), 2 = moderate inflammation (redness, swelling, slight bleeding), 3 = severe inflammation (marked redness/swelling, bleeding on probing). Higher scores indicate more severe inflammation.
Measured: One-time, baseline (July-September 2024)
Periodontal status - Bleeding on Probing (BOP)
Bleeding on probing assessed on all teeth using the Ainamo \& Bay index. Each site was gently probed; presence or absence of bleeding was recorded. Score interpretation: - = no bleeding, + = bleeding present. The percentage of bleeding sites relative to total sites was calculated per participant. Higher percentages indicate greater gingival inflammation.
Measured: One-time, baseline (July-September 2024)
Salivary flow rate
Measured in unstimulated saliva as mL/min; reflects saliva production rate. Higher values indicate greater salivary secretion
Measured: One-time, baseline (July-September 2024)
Salivary pH
Measured in unstimulated saliva using a digital pH meter; reported in pH units. Higher values indicate more alkaline saliva, lower values indicate more acidic saliva.
Measured: One-time, baseline (July-September 2024)
Salivary buffering capacity
Salivary buffering capacity measured using the Ericsson method, reflecting saliva's ability to neutralize acids and maintain pH homeostasis. Reported as a score/units; higher values indicate greater buffering capacity.
Measured: One-time, baseline (July-September 2024)
Salivary melatonin
Measured in unstimulated saliva using ELISA; reported in ng/mL. Melatonin is a hormone involved in sleep regulation and antioxidant defense. Higher values indicate higher melatonin levels.
Measured: One-time, baseline (July-September 2024)
Salivary cortisol
Measured in unstimulated saliva using ELISA; reported in ng/mL. Cortisol is a hormone related to stress response and sleep regulation. Higher values indicate higher cortisol levels.
Measured: One-time, baseline (July-September 2024)
Salivary IL-6
Measured in unstimulated saliva using ELISA; reported in pg/mL. IL-6 is a pro-inflammatory cytokine reflecting oral and systemic inflammation. Higher values indicate higher inflammatory status.
Measured: One-time, baseline (July-September 2024)
Total oxidant status (TOS)
Measured in unstimulated saliva spectrophotometrically; reported in mmol H2O2 equivalent/L. Reflects overall oxidative stress in saliva. Higher values indicate higher oxidant levels.
Measured: One-time, baseline (July-September 2024)
Total antioxidant status (TAS)
Measured in unstimulated saliva spectrophotometrically; reported in mmol Ascorbic acid equivalent/L. Reflects total antioxidant capacity of saliva. Higher values indicate greater antioxidant defense.
Measured: One-time, baseline (July-September 2024)
Oxidative stress index (OSI)
Calculated as the ratio of TOS to TAS; unitless. Reflects the balance between oxidants and antioxidants in saliva. Higher values indicate higher oxidative stress relative to antioxidant capacity.
Measured: One-time, baseline (July-September 2024)
Sleep disturbances
Assessed using the Sleep Disturbance Scale for Children (SDSC, total score ranging from 26 to 130) over the previous 6 months. Higher scores indicate greater risk or severity of sleep problems. A cutoff of 42 points is used; scores above this suggest an increased likelihood of sleep disturbances.
Measured: One-time, baseline (July-September 2024)
Secondary outcomes (9)
Child's toothbrushing frequency
Assessed via parent-completed questionnaire. Categories: "Once daily", "Twice daily", "Irregular".
Measured: One-time, baseline (July-September 2024)
Child's toothbrushing duration
Assessed via parent-completed questionnaire. Categories: "Less than 2 minutes", "2 minutes or more".
Measured: One-time, baseline (July-September 2024)
Parental assistance during toothbrushing
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Measured: One-time, baseline (July-September 2024)
Regular dental floss use
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Measured: One-time, baseline (July-September 2024)
Regular mouthwash use
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Measured: One-time, baseline (July-September 2024)
Child's sex
Assessed via parent-completed questionnaire. Categories: "Male", "Female".
Measured: One-time, baseline (July-September 2024)
Father's education level
Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master's degree".
Measured: One-time, baseline (July-September 2024)
Mother's education level
Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master's degree".
Measured: One-time, baseline (July-September 2024)
Family monthly income
Assessed via parent-completed questionnaire. Categories: "Below minimum wage", "Up to 2x minimum wage", "Up to 3x minimum wage", "More than 3x minimum wage".
Measured: One-time, baseline (July-September 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Jul 2024
- Primary completion10 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427004
- Sponsor's protocol ID
- 20240210
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children
- ClinicalTrials.gov ID
- NCT07427004
- Acronym / sponsor ID
- 20240210
- Conditions
- Dental Caries, Sleep Problems, Periodontal Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dental caries is one of the most prevalent chronic diseases in childhood. In addition to established etiological factors such as dietary habits and oral hygiene, biological and behavioral factors-including sleep disturbances and salivary biochemical characteristics-may contribute to caries development and periodontal health.
Saliva plays a critical role in maintaining oral homeostasis through its physical properties (flow rate, pH, and buffering capacity) and biochemical components. Salivary biomarkers such as melatonin, cortisol, interleukin-6 (IL-6) and oxidative stress parameters (total oxidant status [TOS], total antioxidant status [TAS], and oxidative stress index [OSI]) are associated with sleep regulation, stress response, inflammation and immune function.
This cross-sectional study aims to evaluate the relationship between sleep disturbances and salivary parameters as well as dental caries severity and periodontal status in children aged 6-12 years. A total of 73 children are categorized into two groups according to the International Caries Detection and Assessment System (ICDAS II): children with high-grade caries (codes 5-6) and children who are caries-free or have initial to moderate caries (codes 0-4).
All participants undergo a comprehensive oral examination to assess caries experience, plaque index, gingival index and bleeding on probing. Unstimulated saliva samples are collected to determine salivary flow rate, pH, buffering capacity, melatonin, cortisol, IL-6, TOS, TAS, and OSI levels. Sleep disturbances are evaluated using the Sleep Disturbance Scale for Children
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: Advanced Caries | – | –Study Group (Advanced Caries): Children aged 6-12 years with advanced dental caries (ICDAS codes II 5-6). All participants were systemically healthy and of Turkish ethnicity. |
| Contol Group: Caries-Free / Mild-Moderate Caries | – | –Control Group (Caries-Free / Mild-Moderate Caries): Children aged 6-12 years with no or mild-moderate dental caries (ICDAS II codes 0-4).All participants were systemically healthy and of Turkish ethnicity. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 73 healthy children aged 6-12 years (42 boys and 31 girls) were included in the study. The participants were divided into two groups: the study group (39 children with advanced dental caries, ICDAS II codes 5-6) and the control group (34 children who were caries-free or had initial-moderate caries, ICDAS II codes 0-4). Children with systemic diseases, conditions affecting salivary secretion, or recent use of medications influencing saliva were excluded. Written informed consent was obtained from the parents or legal guardians of all participants. Only children of Turkish ethnicty were included.
Key inclusion criteria (2 listed)
- Children aged 6-12 years
- Children with no systemic diseases
Key exclusion criteria (5 listed)
- Children with systemic or local conditions affecting salivary secretion (diabetes, salivary gland infections, sialoliths, or neurological disorders)
- Children who had used medications affecting salivary secretion in the past three months (antimuscarinics, antihypertensives, or antidepressants)
- Children whose legal guardian did not provide written informed consent
- Children with the history of chemotheraphy or radiotherapy
- Children who are uncooperative with salivary sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dental caries severity
Time frame: One-time, baseline (July-September 2024
Assessed using the International Caries Detection and Assessment System (ICDAS II, codes 0-6) for each primary and permanent tooth. Higher codes indicate more severe lesions. 0 = sound, 1 = first visual change in enamel, 2 = distinct visual change, 3 = localized enamel breakdown, 4 = underlying dark shadow, 5 = distinct cavity, 6 = extensive cavity.
Cumulative caries experience
Time frame: One-time, baseline (July-September 2024)
Assessed using the DMFT + dmft index to record the total number of decayed (D/d), missing (M/m) and filled (F/f) teeth in permanent and primary dentition.
Periodontal status - Plaque index
Time frame: One-time, baseline (July-September 2024)
Plaque accumulation assessed on all teeth using the Silness-Löe plaque index (score 0-3). 0 = no plaque, 1 = slight plaque visible, 2 = moderate plaque, 3 = abundant plaque. Higher scores indicate more plaque accumulation.
Periodontal status - Gingival index
Time frame: One-time, baseline (July-September 2024)
Gingival inflammation assessed on all teeth using the Silness-Löe gingival index (score range 0-3). Scores obtained from each tooth. Score interpretation: 0 = normal gingiva, 1 = mild inflammation (slight color change, no bleeding), 2 = moderate inflammation (redness, swelling, slight bleeding), 3 = severe inflammation (marked redness/swelling, bleeding on probing). Higher scores indicate more severe inflammation.
Periodontal status - Bleeding on Probing (BOP)
Time frame: One-time, baseline (July-September 2024)
Bleeding on probing assessed on all teeth using the Ainamo \& Bay index. Each site was gently probed; presence or absence of bleeding was recorded. Score interpretation: - = no bleeding, + = bleeding present. The percentage of bleeding sites relative to total sites was calculated per participant. Higher percentages indicate greater gingival inflammation.
Salivary flow rate
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva as mL/min; reflects saliva production rate. Higher values indicate greater salivary secretion
Salivary pH
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva using a digital pH meter; reported in pH units. Higher values indicate more alkaline saliva, lower values indicate more acidic saliva.
Salivary buffering capacity
Time frame: One-time, baseline (July-September 2024)
Salivary buffering capacity measured using the Ericsson method, reflecting saliva's ability to neutralize acids and maintain pH homeostasis. Reported as a score/units; higher values indicate greater buffering capacity.
Salivary melatonin
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva using ELISA; reported in ng/mL. Melatonin is a hormone involved in sleep regulation and antioxidant defense. Higher values indicate higher melatonin levels.
Salivary cortisol
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva using ELISA; reported in ng/mL. Cortisol is a hormone related to stress response and sleep regulation. Higher values indicate higher cortisol levels.
Salivary IL-6
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva using ELISA; reported in pg/mL. IL-6 is a pro-inflammatory cytokine reflecting oral and systemic inflammation. Higher values indicate higher inflammatory status.
Total oxidant status (TOS)
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva spectrophotometrically; reported in mmol H2O2 equivalent/L. Reflects overall oxidative stress in saliva. Higher values indicate higher oxidant levels.
Total antioxidant status (TAS)
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva spectrophotometrically; reported in mmol Ascorbic acid equivalent/L. Reflects total antioxidant capacity of saliva. Higher values indicate greater antioxidant defense.
Oxidative stress index (OSI)
Time frame: One-time, baseline (July-September 2024)
Calculated as the ratio of TOS to TAS; unitless. Reflects the balance between oxidants and antioxidants in saliva. Higher values indicate higher oxidative stress relative to antioxidant capacity.
Sleep disturbances
Time frame: One-time, baseline (July-September 2024)
Assessed using the Sleep Disturbance Scale for Children (SDSC, total score ranging from 26 to 130) over the previous 6 months. Higher scores indicate greater risk or severity of sleep problems. A cutoff of 42 points is used; scores above this suggest an increased likelihood of sleep disturbances.
9 secondary outcomes
Child's toothbrushing frequency
Time frame: One-time, baseline (July-September 2024)
Child's toothbrushing duration
Time frame: One-time, baseline (July-September 2024)
Parental assistance during toothbrushing
Time frame: One-time, baseline (July-September 2024)
Regular dental floss use
Time frame: One-time, baseline (July-September 2024)
Regular mouthwash use
Time frame: One-time, baseline (July-September 2024)
Child's sex
Time frame: One-time, baseline (July-September 2024)
Father's education level
Time frame: One-time, baseline (July-September 2024)
Mother's education level
Time frame: One-time, baseline (July-September 2024)
Family monthly income
Time frame: One-time, baseline (July-September 2024)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Sleep Problems, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental caries severity (time frame: One-time, baseline (July-September 2024). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.